Category Archives: Events

01May/19
Living-heart-project

Axendia to Provide Life-Science Analyst Keynote at 3DEXPERIENCE FORUM 2019

Events, Latest, Quality, Regulatory, Technology, ,

Harnessing Positive Disruption in Life Sciences to Achieve Patient-Centric Care

By: Daniel R. Matlis, President

Life-Science organizations must transform or be disrupted! They must harness positive disruption to achieve patient-centric care that supports prevention, improves outcomes as well as providing a holistic patient experience that drives value.

However, to achieve patient-centric care, Life-Science organizations must undergo digital transformation that enables closed loop visibility across the product lifecycle. This transformation requires core paradigm shifts in corporate culture, incentives, strategic planning, regulatory frameworks as well as technological solutions for industry stakeholders.

Male-Anatomy-Background-composite-cropped-low-resNew technologies like modeling and simulation, artificial intelligence and the Internet of Medical Things (IoMT) are enabling patient-centric models to serve more people around the world. The foundation of patient-centric care is the ability to connect the real and digital worlds through multi-discipline, multi-scale modeling and simulation, IoMT connected devices, visibility to data for decision support and greater collaboration. Continue reading →

22Apr/19
Modern-Pharma-Mfg-Small-400by360

FDA is Enabling Innovation and Modernization

Events, Latest, Regulatory, Technology, , ,

By: Thomas O’Connor, Sr. Chemical Engineer, US FDA

FDA is committed to supporting and enabling pharmaceutical innovation and modernization as part of the Agency’s mission to protect and promote public health. FDA recognizes that continuous manufacturing is an emerging technology that can enable pharmaceutical modernization and deliver potential benefits to both industry and patients. Continuous manufacturing can improve pharmaceutical manufacturing by, for example, using an integrated process with fewer steps and shorter processing times; requiring a smaller equipment footprint; supporting an enhanced development approach (e.g., quality by design (QbD) and use of process analytical technology (PAT) and models); enabling real-time product quality monitoring; and providing flexible operation to allow scale-up, scale-down, and scale-out to accommodate changing supply demands. Continue reading →

18Apr/19
logo-infor

What Is Your Human Potential?

Events, Latest, Technology,

Infor 2019 Conference Event Brief

By: Eric M. Luyer, Industry Research Analyst

Last week I was inspired by the great conference  “INSPIRE” that was organized by Infor in Amsterdam, The Netherlands. The tagline for this conference was the question: “What is your Human Potential?”  The conference amazed the attendees with a series of presentations on Infor products, their potential, and responses to questions on how to best deploy lnfor’s latest technologies around new applications for various types of industries and different user-levels.

Elevating Human Potential Through Innovation in Science and Technology

It is clear that Infor has its roots in Manufacturing and Distribution as they elaborated on their capabilities in their space using the latest technologies, such as business analytics (with BIRST), artificial intelligence (with Coleman), and the challenges around digital transformation.

Register to read the full event brief.

22Mar/19
modernizing pharma manuf image

FDA Shares Quality Considerations for Continuous Manufacturing

Events, Latest, Regulatory, Technology, , ,

A Straight from the Source Webinar

 FDA is committed to supporting and enabling pharmaceutical innovation and modernization. The Agency recognizes that continuous manufacturing is an emerging technology that can enable pharmaceutical modernization and deliver potential benefits to both industry and patients.

Join FDA’s Thomas O’Connor, Ph.D. and Axendia’s Daniel R. Matlis for a live webinar.

Date and Time:  April 17th at 11:00 AM ET. 

We will discuss FDA’s perspective on pharmaceutical innovation and modernization including:

  • FDA’s draft guidance on Quality Considerations for Continuous Manufacturing
  • How continuous manufacturing can improve pharmaceutical manufacturing
  • Support of enhanced development approaches such as quality by design (QbD), process analytical technology (PAT) and models
  • Insights from dialogue with sponsors through the Emerging Technology Program, externally funded and internal research
  • Experiences from review and approval of five drug applications utilizing continuous manufacturing to date

Meet Your Trusted Sources

dan and thomas SFTS image

Scheduling Conflict? Register and receive a link to view the on-demand recording after the event.

Participation is Limited!

register

05Mar/19
Radar Square for LSP-Zoom only-extra small

Disruption is on the Radar! You Must Plot a Course for Success.

Business, Events, Latest, Regulatory, Technology,

Webinar Available On-Demand

Disruption is on the radar! Life-Science executives must plot a course for success.  That was the theme of our “Straight from the Source” webinar featuring Axendia’s President, Daniel R. Matlis and Sandra K. Rodriguez, Market Analyst, on February 20th.

Since 2005, Industry stakeholders and regulators have relied on Axendia for trusted advice on Business, Regulatory and Technology issues and trends.  Due to our track-record of accurately predicting Life-Science trends, our clients often ask us to forecast what’s on the horizon.

To answer this question, we developed a Life Science radar to communicate our focus areas in the markets we service, as well as share when we predict these trends will become mainstream. Continue reading →